RECRUITING

ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients

Conditions

Recurrent Oligodendroglioma Progressive Oligodendroglioma Immunotherapy Brain Tumor

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will enroll 6 DLT evaluable subjects (up to 12 patients total) where we will evaluate feasibility and safety of adoptive cellular therapy combined with IDH1/2 inhibitors in patients with recurrent or progressive oligodendroglioma WHO grade 2 and WHO grade 3.

Official Title

ADAGiO: Adoptive Cellular Therapy for the TreAtment of Recurrent OliGodendrogliOma (OG) Adult Patients

Quick Facts

Study Start:2024-09-19

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06254326

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male or female, aged 18 years and above * Tumor tissue obtained on a screening consent is available. * Confirmed with recurrent/progressive IDH-mutant 1p/19q co-deleted Oligodendroglioma WHO grade 2 or WHO grade 3, more than 12 weeks from completion of radiation. * Karnofsky Performance Status ≥ 60 * Must be a candidate for surgery/biopsy * Adequate bone marrow and organ function as defined below: * ANC ≥ 1,000/mcL * Platelets ≥ 100,000/mcL * Hemoglobin ≥ 9 g/dL (can be transfused) * Serum creatinine ≤ 1.5 x IULN OR Creatinine clearance by Cockcroft-Gault ≥ 60 mL/min for patients with serum creatinine \> 1.5 x IULN * Serum total bilirubin ≤ 1.5 x IULN OR Direct bilirubin ≤ IULN for patients with total bilirubin \> 1.5 x IULN * AST (SGOT) and ALT (SGPT) ≤ 3 x IULN * For females of childbearing potential, negative serum pregnancy test at enrollment * For women and men of childbearing potential (WOCBP) must be willing to use acceptable contraceptive methods	* Disease progression during treatment with an anti-IDH-1 or anti IDH-2 * Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. * Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement. * Multifocal disease. * Corticosteroids equivalent to ≥ 4mg dexamethasone daily. * HIV, Hepatitis B, or Hepatitis C seropositive. * Known active infection or immunosuppressive disease. * Autoimmune disease requiring medical management with immunosuppressant. * Pregnancy or lactation, due to possible adverse effects on the developing fetus or infant. * Treatment with another investigational drug or other intervention within 30 days prior to projected first dose of study treatment (Priming phase with TTRNA-DC). * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization. * Transmural myocardial infarction within the last 6 months. * Acute bacterial or fungal infection requiring intravenous antibiotics at time of enrollment. * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy. * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. * Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.

Inclusion Criteria

Exclusion Criteria

* Male or female, aged 18 years and above
* Tumor tissue obtained on a screening consent is available.
* Confirmed with recurrent/progressive IDH-mutant 1p/19q co-deleted Oligodendroglioma WHO grade 2 or WHO grade 3, more than 12 weeks from completion of radiation.
* Karnofsky Performance Status ≥ 60
* Must be a candidate for surgery/biopsy
* Adequate bone marrow and organ function as defined below:
* ANC ≥ 1,000/mcL
* Platelets ≥ 100,000/mcL
* Hemoglobin ≥ 9 g/dL (can be transfused)
* Serum creatinine ≤ 1.5 x IULN OR Creatinine clearance by Cockcroft-Gault ≥ 60 mL/min for patients with serum creatinine \> 1.5 x IULN
* Serum total bilirubin ≤ 1.5 x IULN OR Direct bilirubin ≤ IULN for patients with total bilirubin \> 1.5 x IULN
* AST (SGOT) and ALT (SGPT) ≤ 3 x IULN
* For females of childbearing potential, negative serum pregnancy test at enrollment
* For women and men of childbearing potential (WOCBP) must be willing to use acceptable contraceptive methods

* Disease progression during treatment with an anti-IDH-1 or anti IDH-2
* Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years.
* Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.
* Multifocal disease.
* Corticosteroids equivalent to ≥ 4mg dexamethasone daily.
* HIV, Hepatitis B, or Hepatitis C seropositive.
* Known active infection or immunosuppressive disease.
* Autoimmune disease requiring medical management with immunosuppressant.
* Pregnancy or lactation, due to possible adverse effects on the developing fetus or infant.
* Treatment with another investigational drug or other intervention within 30 days prior to projected first dose of study treatment (Priming phase with TTRNA-DC).
* Severe, active co-morbidity, defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization.
* Transmural myocardial infarction within the last 6 months.
* Acute bacterial or fungal infection requiring intravenous antibiotics at time of enrollment.
* Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy.
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
* Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
* Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.

Contacts and Locations

Study Contact

Phuong Deleyrolle, RN

CONTACT

352-273-9000

phuong.deleyrolle@neurosurgery.ufl.edu

Principal Investigator

Duane Mitchell, MD, PhD

STUDY_CHAIR

University of Florida

Ashley Ghiaseddin, MD

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

University of Florida Health Shands Hospital

Gainesville, Florida, 32610

United States

Collaborators and Investigators

Sponsor: University of Florida

Duane Mitchell, MD, PhD, STUDY_CHAIR, University of Florida
Ashley Ghiaseddin, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-19

Study Completion Date2028-06

Study Record Updates

Study Start Date2024-09-19

Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

Immunotherapy
Brain Tumor

Additional Relevant MeSH Terms

Recurrent Oligodendroglioma
Progressive Oligodendroglioma